Pulmonary Hypertension in Patients With Sickle Cell Disease in Nigeria
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00367523|
Recruitment Status : Completed
First Posted : August 23, 2006
Last Update Posted : May 18, 2018
This study will explore how people with sickle cell disease (SCD) develop a complication called pulmonary hypertension (PHTN), a serious disease in which blood pressure in the lungs is higher than normal. PHTN is also caused by HIV, hepatitis C and schistosomiasis. Patients who have both SCD and one of these other infections may develop more severe PHTN. The number of Nigerians with SCD who also have PHTN is not known, nor is the cause of PHTN in this population. This study will examine genetic material in people with and without SCD to determine whether certain genes will allow doctors to predict which patients with SCD are likely to develop PHTN.
Nigerian males and females 10 years of age and older with or without SCD may be eligible for this study. Patients must have SS, SC, or SB thalassemia or other genotype; control subjects must have hemoglobin A or AS genotype.
Participants undergo a complete medical history and physical examination, blood tests, electrocardiogram (EKG), ultrasound tests of the heart and abdomen, and a 6-minute walk (distance test) to determine exercise capacity. Blood tests include screening for HIV, hepatitis B and C, schistosomiasis, hookworm and malaria. Patients who test positive for HIV, hepatitis B or C, schistosomiasis, hookworm or malaria are referred for treatment at Ahmadu Bello University Teaching Hospital in Zaria, Nigeria, and those who test negative for hepatitis B are referred for vaccination. Genetic tests focus on genes involved in SCD, PHTN, inflammation, blood vessel function and red blood cell function.
|Condition or disease|
|Secondary Pulmonary Arterial Hypertension Sickle Cell Disease Pulmonary Hypertension|
|Study Type :||Observational|
|Actual Enrollment :||308 participants|
|Official Title:||Prevalence of Secondary Arterial Hypertension (PAH) in Patients With Sickle Cell Disease in Nigeria and the Role of HIV/AIDS and Endemic Parasitic Infections in the Natural History of Pulmonary Hypertension in Sickle Cell Disease|
|Study Start Date :||June 15, 2006|
|Study Completion Date :||September 28, 2017|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00367523
|Ahmadu Bello University Teaching Hospital|
|Principal Investigator:||Swee Lay Thein, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|